[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ige-mediated-hypersensitivity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ige-mediated-hypersensitivity":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100624379","phase-1-a-phase-1-study-of-cizutamig-in-ige-mediated-diseases-100624379",false,"NCT07408869","A Phase 1 Study of Cizutamig in IgE Mediated Diseases","A Phase 1b, Open-Label Study Evaluating the Pharmacodynamics, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Cizutamig in IgE Mediated Diseases","Inclusion Criteria:\n\n1. Patient meets at least one of the following:\n\n   1. History of documented (skin prick test, in vitro testing, or food challenge), ongoing, IgE-mediated allergy to food (eg, peanut, hazelnut, walnut, cashew, milk, egg\u002Fegg white, soy, wheat, sesame, cod, salmon, tuna, lobster, crab and\u002For shrimp) with Screening total IgE ≥ 400 IU\u002FmL\n   2. Diagnosis of chronic rhinosinusitis with Screening total IgE \\> ULN\n   3. Diagnosis of allergic rhinitis with Screening total IgE \\> ULN\n   4. Diagnosis of asthma and classified as well controlled per 2024 Global Initiative for Asthma guidelines with Screening total IgE \\> ULN\n   5. Diagnosis of chronic spontaneous urticaria with symptoms (eg, wheals or angioedema) for at least 6 weeks any time prior to screening and Screening total IgE \\> ULN\n   6. Diagnosis of atopic dermatitis that has been present for at least 6 months before the screening visit and with Screening total IgE \\> ULN\n2. Agree to the use of highly effective contraception\n\nExclusion Criteria:\n\n1. Elevated IgE levels for reasons other than the IgE mediated diseases\n2. Planned ingestion of food items to which they are allergic for the duration of the study (for food allergy patients)\n3. Current use of any allergen immunotherapy.\n4. Individuals whose allergen exposures in their home and\u002For work environments may be expected to change significantly during the trial period\n5. Inadequate clinical laboratory parameters at Screening\n6. Receipt of or inability to discontinue any excluded therapies\n7. Individuals who will decline blood products\n8. Active infection\n9. Serious mental illness, drug or alcohol abuse, dementia, or other condition that impair ability to sign ICF\n10. Individuals who are hypersensitive to intravenous immunoglobulin (IVIg)\n11. History of primary immunodeficiency\n12. History of CNS disease\n13. History of poorly controlled diabetes, chronic kidney disease, chronic pulmonary disease, uncontrolled cardiovascular disease, history of malignancy within 5 years\n14. History of severe allergic or anaphylactic reactions to mAb therapy (or recombination antibody-related fusion proteins) or any constituents of study drug\n15. Major surgery requiring the use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period\n16. Blood donation or significant blood loss within 30 days prior to screening\n17. Individuals considered to be part of a vulnerable population (eg, incarceration)\n18. Individuals that in the opinion of the Investigator, are not suitable for participation in the trial\n19. Inability to comply with protocol-mandated requirements\n20. A history of severe allergic or anaphylactic reactions related to the underlying IgE mediated disease","ALL","18 Years","65 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and immunogenicity of cizutamig in IgE Mediated Diseases.",[27,28,29],"IgE-Mediated Hypersensitivity","IgE Mediated Food Allergy","IgE-Mediated Cow Milk Allergy",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55],"peanut allergy","nut allergy","hazelnut allergy","walnut allergy","cashew allergy","milk allergy","egg allergy","soy allergy","wheat allergy","sesame allergy","cod allergy","salmon allergy","tuna allergy","lobster allergy","crab allergy","shrimp allergy","food allergy","rhinosinusitis","allergic rhinitis","asthma","urticaria","atopic dermatitis","immune system","cizutamig","T cell engager","NOT_YET_RECRUITING","2026-04-14",{"date":59,"type":60},"2026-04-16","ACTUAL",{"date":62,"type":21},"2026-04",{"date":64,"type":21},"2026-12",{"name":66,"class":67},"Candid Therapeutics","INDUSTRY",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":16,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":92,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":68},"100617272","birth-cohort-development-of-ige-autoantibodies-in-newborns-with-high-risk-of-atopic-dermatitis-100617272","NCT07316465","Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis","Development of IgE Autoantibodies in Newborns With Atopic Dermatitis (DIANA) Birth Cohort","DIANA","Inclusion Criteria:\n\nNewborns who are planned to be born at the maternity ward of UZ Brussel with the following criteria:\n\n* 400 newborns with high-risk for AD-development (at least 1 parent or sibling with physician diagnosed atopic dermatitis AND\u002FOR asthma AND\u002FOR allergic rhinitis)\n* 100 newborns with low-risk for AD-development (no parents or siblings with history of atopic dermatitis AND\u002FOR asthma AND\u002FOR allergic rhinitis)\n\nExclusion Criteria:\n\n* Newborns not born at the maternity ward of UZ Brussel\n* Parents with a poor understanding of Dutch, French or English\n* Newborns who are admitted post-partum to the neonatal intensive care unit (gestational age \\\u003C34 weeks) or with medical complications\n* Newborns with severe genetic abnormalities\u002Fbirth defects\n* Newborns whose parents will not be able to attend the study visits for a period of 2 years (location, working hours)",true,"1 Hour","24 Months",{"count":81,"type":21},500,[83],"NA","Previous research has shown that some patients with atopic eczema have specific self-reactive antibodies, known as IgE autoantibodies, that react to their own skin cells, referred to as \"self-reactive antibodies\" or \"autoantibodies\". It is not yet known when and how these self-reactive antibodies develop, so this is what we aim to investigate.\n\nThis study aims to examine the presence of self-reactive antibodies at birth. In other words, the investigators want to study the earliest stage of developing antibodies that target the body's own skin cells. Additionally, factors that contribute to the development of these self-reactive antibodies will be explored as well as the correlation with the development of atopic eczema.\n\nThe study will involve newborns who are at an increased risk of developing atopic eczema due to a family history of asthma, hay fever, or atopic eczema. There will also be a control group of newborns without these characteristics. The study's approach is to examine a portion of the umbilical cord blood, which is routinely collected after birth, to investigate self-reactive antibodies. The goal is to determine whether these self-reactive antibodies are linked to the development of atopic eczema in the first two years of life. For this purpose, follow-ups will be conducted at the ages of 6, 12, and 24 months.\n\nThis study will contribute to an increased understanding of the prevalence of self-reactive antibodies and the factors influencing their development. Moreover, the study will determine whether these antibodies play a role in the prevention of and\u002For serve as predictive factors for the development of atopic eczema.",[86,87,88,89,90,27,91],"Atopic Dermatitis (AD)","Autoantibody","Auto-Immunity","Microbiome, Human","Allergic Disease","Newborn Infant",[93,94,95,96,75],"Birth cohort","Autoantibodies","IgE","Atopic dermatitis","RECRUITING","2025-12-18",{"date":100,"type":60},"2026-01-05",{"date":102,"type":60},"2023-10-01",{"date":104,"type":21},"2030-12-31",{"name":106,"class":107},"Universitair Ziekenhuis Brussel","OTHER"]